200503
Publication of Findings from Clinical Trials
POSITION STATEMENT
Approved by the Board of Trustees, July 2005
Approved by the Assembly, May 2005
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"Policy documents are approved by the APA Assembly and Board of Trustees… These are …position statements that define APA official policy on specific subjects…" -- APA Operations Manual. |
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This document states the position of the American Psychiatric Association (APA) on the publication rights of researchers participating in clinical trials and on the broader issue of participation in a national, comprehensive, clinical trials registry as a condition for publication in peer-reviewed scientific journals.
The APA believes that all researchers should have the freedom to contribute to the design of clinical trials and to publish all findings from the trials in which they participate regardless of outcome. APA thus discourages investigators who participate in clinical trials research from entering into agreements with trial sponsors that place restrictions of any kind on the right to publish.
Simultaneously, APA urges Institutional Review Boards (IRBs) and journal editors to require researcher assurances of unfettered access to methodology, findings and results as a condition of approval and of publication, respectively. Public accessibility to all methods and findings related to clinical trials has direct implications for improved patient care and treatment, while the suppression of negative findings has the potential of exposing patients to ineffective and potentially harmful treatments.
With regard to the overarching issue of research integrity in the conduct of clinical trials, APA believes that a comprehensive public registry of all clinical trials initiated in the United States, whether publicly – or privately-funded, will go a long way toward alleviating the mistrust and doubt currently surrounding published data on the efficacy and safety of medications for children and for adults diagnosed with mental disorders.
The APA supports and advocates for legislation mandating and funding a national registry initiative to be implemented by the National Institutes of Health in accordance with principles and procedures already established and successfully implemented in other comprehensive national and international databases.
As part of the legislation on this subject, the APA strongly encourages inclusion of provisions—directed toward IRBs and scientific journals—that require registration and assignment of unique trial identifiers as conditions of IRB approval and of journal publication.
Additionally, in the interest of improved ethical standards and public safety, the APA encourages legislative provisions that require registration as a necessary condition for clinician referral and for patient participation in clinical trials.